1. mHealth Roundup Apps for Consumers & Providers
Rita Sieracki, Medical College of WI Libraries

2. Are you fertile. Too sedentary. Need advance medical directives
Are you fertile? Too sedentary? Need advance medical directives? Does this ankle need an x-ray? Want better heart health? Are you taking your meds?

3. There’s an app for that!

4. Almost two-thirds (66%) of Americans would use a mobile app to manage health-related issues.
Millenials are more than twice as likely to express interest in using mobile app to manage their health compared to those Americans 66 and older.

5. 165,000 mHealth apps – Apple & Google - 2015
Of the 165,000 health related apps a mere 36 comprise 50 % of the downloads, 40% of apps have fewer than 5,000 downloads

6. Assessment of Consumer mHealth App Functionality
Over 50% have limited functionality, most just provide information

7. Top 5 Disease Specific Apps for 2015
Mental health apps led among disease specific apps, followed by diabetes.
Source: Mevvy, June 2015; IMS Institute for Health Care Informatics

8. Apps Prescribed by Providers
More than 1/3 of physicians have recommended mHealth apps
to patients

9. Barriers to use of mHealth apps: lack of scientific evidence, lack of integration into workflow systems, regulatory and privacy unknowns
Source: Mevvy, June 2015; IMS Institute for Health Care Informatics

10. 1,761 articles in PubMed on mHealth
Half have been published since 2016

11. Source: Mevvy, June 2015; IMS Institute for Health Care Informatics

12. 372 clinical trials for mHealth in ClinicalTrials.gov
219 in US, Most notable and positive evidence in area of Type II diabetes, cardiovascular health, obesity, multiple sclerosis. Over half target seniors

13. “Standard care with the addition of Mobile Thrive (M-Thrive), our innovative smart phone-based mobile app, is intended to demonstrate the clinical advantages of using mobile health technology (mHealth) in comparison to standard care alone.”
clinicaltrials.gov

14. Type of Smartphone App Clinical Trials
Most notable and positive evidence in area of Type II diabetes, cardiovascular health, obesity, multiple sclerosis
Source: ClinicalTrials.gov; IMS Institute for Healthcare Informatics, August 2015

15. Makeup of Patients Enrolled in mHealth App Clinical Trials
Source: ClinicalTrials.gov; IMS Institute for Healthcare Informatics, August 2015

16. Three tier risk-based approach used to assure safety and effectiveness of medical devices

17. Regulated Apps – Class III – High Risk
Control other devices
Display, store, analyze or transmit patient-specific medical data from another device
Use attachments, display screens, or sensors to transform the mobile platform into a medical device
Perform patient-specific analysis and provide patient specific diagnosis or treatment recommendation

18. Some Examples of Class III – High Risk Apps
Mobile apps that:
use an attachment to the mobile platform to measure blood glucose levels.
analyze an image of a skin lesion using mathematical algorithms and provide the user with an assessment of the risk of the lesion.
alter the function or settings of an infusion pump.
 control the inflation or deflation of a blood-pressure cuff.

19. Apps subject to enforcement discretion – Class II – Moderate Risk
Provide or facilitate supplemental care by coaching or prompting patients
Tools to help patients organize or track health information
Provide access to information related to health conditions or treatments
Allow patients to communicate medical conditions with providers
Perform simple calculations used in clinical practice
Enable individuals to interact with electronic health records

20. Some Examples of Class II – Moderate Risk Apps
Mobile apps that:
provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women
keep track of medications and provide user-configured reminders for improved medication adherence
allow a user to collect, log, track, and trend data, such as blood glucose, blood pressure, heart rate, weight, or other data from a device to eventually share with a health care provider 

21. Apps that will not be regulated –
Class I – Low Risk
Electronic copies of medical textbooks, teaching aids, or other reference material
Intended as educational tools for medical training
Facilitate patient access or understanding
Automate general office operations
Not specifically designed or intended for medical purposes

22. Some Examples of Class I – Low Risk Apps
Electronic copies of medical textbooks or literature articles such as the PDR or DSM-IV
Encyclopedia of first-aid or emergency care information
Medical flash cards with medical images, pictures, graphs
Medical board certification or recertification preparation
Allow users to input pill shape, color, or imprint and displays pictures and names of pills that match this description

23. HIPAA
The key to understanding whether HIPAA comes into play is understanding who is collecting the data, why the data are being collected, and who will use the data.

24. If a patient uses the app independently of a clinician’s advice and does not transmit any of the data collected by the app, it is likely that the app falls completely outside of the HIPAA realm
When patients’ health information is in the possession of health providers, health plans, business associates, or other covered entities, it is protected under HIPAA.
HIPAA also does not cover information on an individual’s mobile device.

25. Privacy 600 most common apps,
only 31 % had privacy policies at all required
reading level of such policies was typically at a college level
66 % of these privacy policies consisted of legal “boilerplate” that did not even mention the specific app in question
Glenn T, Monteith S. Privacy in the digital world: medical and health data outside of HIPAA protections. Curr Psychiatry Rep.2014;16(11):494.

26. Healthcare-related data may be collected and sold by the app company for uses that the patient never imagined.
Some patients may accept the tradeoff of privacy for the convenience or other services offered by the app, others will not.
88 percent of Americans would be willing to share their personal information for the sake of improving care and treatment options.
Glenn T, Monteith S. Privacy in the digital world: medical and health data outside of HIPAA protections. Curr Psychiatry Rep.2014;16(11):494.

27. Clinicians will find it important to educate patients about the potential lack of confidentiality associated with apps offering “treatment” outside of a healthcare setting governed by HIPAA.

28. American Medical Association
Consult attorney if you are unsure whether an mHealth app meets HIPAA standards
Ask about applicable state privacy & security laws
The AMA will examine the potential liability risks to physicians for using, recommending or prescribing mHealth apps, including risk under federal and state medical liability, privacy and security laws.

29. Liability Questions
If an app provides inaccurate data that causes a clinician to mismanage a condition, how should liability be apportioned?
Additionally, if a patient makes mistakes in the use of an app and this results in mismanagement of her condition, to whom will blame ultimately be assigned?

30. Liability Questions
If a physician prescribed medication-related app erroneously advises the patient to take medications other than as prescribed—or otherwise malfunctions—and the patient suffers harm.
Who is liable: the patient, the app makers, or the clinician?
it certainly appears prudent to consider and discuss, as a standard part of informed consent, any foreseeable harm from apps before recommending them in clinical practice.

31. Liability Questions
Establishing an agreement around the use of any app with the patient may help to avoid misunderstandings that could lead to adverse outcomes.

32. Acne applications which purported to treat acne by shining a light from a smartphone on the user’s face
$2 million settlement against a “brain training” app (Lumosity) which purported to reduce or delay cognitive impairments associated with age or health conditions
Given the sheer volume of apps flooding the marketplace and a reactive (rather than proactive) approach to the policing of claims, the FTC is currently serving a rather limited role in app regulation

33. Application which claimed to calculate a mole’s risk of melanoma
$150,000 fine UltimEyes app that claimed to improve visual acuity (company doesn’t provide enough proof that the app works)
Application which claimed to calculate a mole’s risk of melanoma
Given the sheer volume of apps flooding the marketplace and a reactive (rather than proactive) approach to the policing of claims, the FTC is currently serving a rather limited role in app regulation

34. designed to help the developers understand what federal laws and regulations  might apply to their apps; questions about the nature of their app, including about its function, the data it collects, and the services it provides to users. Based on the developer’s answers to those questions, the guidance will point the app developer toward detailed information about certain federal laws that might apply to the app.

35. Lawsuit Fitbit Class action lawsuit - 2016 Consumers in CA, CO and WI
Heart rate tracking is inaccurate

36. Lawsuit Fitbit Class action lawsuit - 2016 Consumers in CA, CO and WI
Sleep tracking technology
Suit claims overestimates sleep by 63 minutes
An evaluation of popular WAMs (wearable activity monitors) revealed error rates ranging from 17 to 18%.

37. There’s an app for that! But is it any good?
no standardized method of review exists, reviews in iTunes or Google play are unreliable

38. Mobile Application Rating Scale (MARS)
Engagement – fun, entertaining to use
Functionality – does it work, easy to use
Aesthetics – overall visual appeal
Information – Contains high quality information (e.g. text, feedback, measures, references) from a credible source.
Subjective Quality – would you recommend, would you pay for it, how often would you use it
Perceived Impact – impact for the user
Researchers from Australia’s Queensland University created The MARS is a simple, objective, and reliable tool FORM for classifying and assessing the quality of mobile health apps

39. physicians, allied health professionals, medical trainees, and mHealth analysts in providing reviews, research, and commentary of mobile medical technology – apps for both physicians and consumers, started by medical student in 2009

40. For the initial providers that sign up to use the beta -- there will be no cost to you or your patients.

41. IMS Health AppScript Score Overview
curated 40,000 health apps, Health app prescription platform,

42. Professionals and consumers score for
Operability
Privacy and Security
Consumer appeal
Functionality
Usability
Then give a grade of A, B or C.

43. Apps available at MCW Libraries
Current awareness tool for reading electronic journals on tablets, phones or on the web.

44. clinical information resource designed to provide health care professionals concise, practical answers needed at the point of care.

45. 25,000 medical images and specialist-level knowledge to help diagnose, treat, and manage over 1,200 visually identifiable diseases, drug reactions, and infections

46. books, journals, videos and images

47. Questions?